Randomized Clinical Study of Intraaortic Balloon Pump Use in Cardiogenic Shock Complicating Acute Myocardial Infarction
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 600
- 试验地点
- 40
- 主要终点
- 30-day mortality
研究概览
简要总结
Patients in cardiogenic shock complicating acute myocardial infarction (AMI) are referred to a tertiary care center for percutaneous coronary intervention (PCI) of the infarct related artery in this multicenter, ran-domized clinical trial. After checking in- and exclusion criteria computerized randomization is performed to either PCI plus intraaortic balloon pump (IABP) insertion and medical treatment or PCI plus medical treatment only. Intensive care treatment is performed according to standard care including hemodynamic monitoring using a pulmonary artery catheter for optimal volume status adaptation and inotropic drug administration.
The IABP will be weaned after hemodynamic stabilization. Primary outcome measure will be 30-day mortality. The secondary outcome measures such as hemody-namic, laboratory and clinical parameters will serve as surrogate for prognosis of the patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cardiogenic shock complicating acute myocardial (STEMI or NSTEMI) with
- •intended revascularization (PCI or CABG)
- •Systolic blood pressure < 90 mmHg > 30 min or inotropes required to maintain pressure > 90 mmHg during systole
- •Signs of pulmonary congestion
- •Signs of impaired organ perfusion with at least one of the following:
- •Altered mental status
- •Cold, clammy skin
- •Urine output <30 ml/h
- •Serum lactate >2mmol/l
- •Informed consent
排除标准
- •Resuscitation > 30 minutes
- •Cerebral deficit with fixed dilated pupils
- •No intrinsic heart action
- •Mechanical infarction complication
- •Onset of shock > 12 h
- •Severe peripheral artery disease
- •Aortic regurgitation > II.°
- •Age > 90 years
- •shock of other cause
- •Other severe concomitant disease
- •participation in another trial
结局指标
主要结局
30-day mortality
时间窗: 30 day
次要结局
- Inflammatory markers (CRP and white blood cell count)(4 days)
- Creatinine clearance until stabilization(4 days)
- Hemodynamic Parameters (Blood pressure, Heart rate)(3 days)
- requirement for hemofiltration or dialysis(4 days)
- requirement for active assist device implantation or heart transplantation at 30 days and approximately 60 months(60 months)
- quality of life at 30 days and approximately 60 months(60 months)
- Time till hemodynamic stabilization(30 days)
- Catecholamine dose and duration of catecholamines(30 days)
- Mean and area under the curve of serum lactate(48 hours)
- length of ICU stay(30 days)
- length of mechanical ventilation(30 days)
- SAPS-II Score(4 days)
- long-term mortality at 6, 12 and approximately 60 months(60 months)
研究者
Holger Thiele
Deputy Director
University of Leipzig